Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet - A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
The goal of this clinical trial is to assess the impact of combination therapy with Naltrexone-Bupropion (NB) in the post-operative period of sleeve gastrectomy (SG). on a) weight loss, b) resolution of comorbidities and c) eating behaviors.
Researchers will compare SG-NB group with SG-placebo group to see if they experience significantly higher excess weight loss (EWL) at 12 and 24 months and if there is a significantly higher percentage of patients with an EWL above 50% in the SG-NB group versus in the SG-placebo group.
Participants will be randomized 1:1 to SG in combination with NB versus SG with placebo. Patients will be started one month after surgery on a progressive dose of Naltrexone/Bupropion extended-release or placebo. Duration of therapy will be 24 months.Both groups will benefit from behavioral and nutritional support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities.
排除标准
- •Revisional or reoperative surgery
- •Pregnancy or planned pregnancy in the next 24 months
- •Simultaneous use of other weight loss medication
- •Uncontrolled hypertension
- •Chronic opioid use or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal.
- •Use of other bupropion-containing products
- •Concomitant administration of monoamine oxidase inhibitors.
- •End-stage liver or kidney disease
- •Concomitant use of CYP2B6 inhibitors (ticlopidine or clopidogrel)
- •Concomitant administration of the antipsychotic thioridazine
- •Seizure disorder or a history of seizures
- •Cardiac pacemaker
- •Current or prior diagnosis of bulimia or anorexia nervosa
研究组 & 干预措施
Naltrexone/Bupropion
Patients will be started one month after sleeve gastrectomie on a progressive dose of Naltrexone/Bupropion extended-release 8mg/90mg, up to 2 tabs twice a day (32mg/360mg) adjusted according to tolerance and side-effects.
干预措施: Naltrexone/Bupropion (Drug)
Placebo
Patients will be started one month after sleeve gastrectomie on a progressive numbers of matched placebo tablets up to 2 tabs twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Weight loss
时间窗: baseline to 24 months
% Excess weight loss
Percentage of participant with an Excess Weight Loss above 50%
时间窗: Baseline to 24 months
次要结局
- Improvement of Eating behaviors (Food Craving Trait Questionnaire)(Baseline to 24 months)
- Decrease in food explicit and implicit wanting and liking food reward.(Baseline to 24 month)
- Improvement in well-being, mood and Quality of Life (SF-36)(Baseline to 24 months)
- Resolution of associated comorbidities(Baseline to 24 months)
- Improvement of Eating behaviors (Food Craving State Questionnaire)(Baseline to 24 months)
- Improvement in well-being, mood and Quality of Life (QLaval)(Baseline to 24 months)
- Improvement in well-being, mood and Quality of Life (HAD questionnaire)(Baseline to 24 months)
- Gastro-intestinal side-effects(Baseline to 24-month)
- Improvement of Eating behaviors (Binge Eating Scale)(Baseline to 24 months)
- Improvement of Eating behaviors (YFAS 2.0)(Baseline to 24 months)
研究者
Laurent Biertho
Principal Investigator
Laval University